FDA inspection of China-based site making Coherus' potential new cancer drug ends with three observations
After Covid-related delays that forced the FDA to delay its China-based inspections, Coherus BioSciences said today that its China-based partner Junshi Biosciences has now successfully completed the required pre-approval inspection for its PD-1 toripalimab, which is being made at a site in China, with three observations.
“The Company believes that the three observations received at the close of the FDA inspection are readily addressable and, together with Junshi Biosciences, plans to submit the response to the FDA in early June,” Coherus said in an SEC filing. The company did not disclose the observations, but Coherus’ stock price $CHRS fell by almost 8% on Wednesday.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.